Guidewire devices having shapeable tips and bypass cuts

ABSTRACT

The present disclosure relates to guidewire devices having shapeable tips and effective torquability. A guidewire device includes a core having a proximal section and a tapered distal section. A tube structure is coupled to the core such that the tapered distal section extends into the tube structure. The tube structure includes a plurality of bypass cuts formed tangentially within the tube structure to increase the flexibility of the tube structure and to reduce the tendency of resilient forces from the tube structure to disrupt a shaped distal tip of the guidewire device.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority to and the benefit of U.S. ProvisionalPatent Application Ser. No. 62/363,760, filed Jul. 18, 2016 and titled“GUIDEWIRE DEVICES HAVING SHAPEABLE TIPS,” the disclosure of which isincorporated herein by this reference in its entirety.

BACKGROUND

Guidewire devices are often used to lead or guide catheters or otherinterventional devices to a targeted anatomical location within apatient's body. Typically, guidewires are passed into and through apatient's vasculature in order to reach the target location, which maybe at or near the patient's heart or neurovascular tissue, for example.Radiographic imaging is typically utilized to assist in navigating aguidewire to the targeted location. In many instances, a guidewire isleft in place within the body during the interventional procedure whereit can be used to guide multiple catheters or other interventionaldevices to the targeted anatomical location.

Some guidewire devices are constructed with a curved or bent tip toenable an operator to better navigate a patient's vasculature. With suchguidewires, an operator can apply a torque to the proximal end of theguidewire or attached proximal handle in order to orient and point thetip in a desired direction. The operator may then direct the guidewirefurther within the patient's vasculature in the desired direction.

Tuning the flexibility of a guidewire device, particularly the distalsections of the guidewire device, is also a concern. In manycircumstances, relatively high levels of flexibility are desirable inorder to provide sufficient bendability of the guidewire to enable theguidewire to be angled through the tortuous bends and curves of avasculature passageway to arrive at the targeted area. For example,directing a guidewire to portions of the neurovasculature requirespassage of the guidewire through curved passages such as the carotidsiphon and other tortuous paths.

Another concern related to guidewire devices is the ability of a givenguidewire device to transmit torque from the proximal end to the distalend (i.e., the “torquability” of the guidewire device). As more of aguidewire is passed into and through a vasculature passageway, theamount of frictional surface contact between the guidewire and thevasculature increases, hindering easy movement of the guidewire throughthe vasculature passage. A guidewire with good torquability enablestorquing forces at the proximal end to be transmitted through theguidewire to the distal end so that the guidewire can rotate andovercome the frictional forces.

Some guidewire devices include a distally placed micro-machined hypotubepositioned over the distal end of the guidewire core in order to directapplied torsional forces further distally toward the end of the device.Because torsional forces are primarily transmitted through the outersections of a cross-section of a member, the tube is configured toprovide a path for increased transmission of torque as compared to theamount of torque transmitted by a guidewire core not sheathed by a tube.Typically, such tubes are formed from a superelastic material such asnitinol so as to provide desired torque transmission characteristics inaddition to providing good levels of flexibility.

While such guidewire devices have provided many benefits, severallimitations remain. For example, many of the design characteristics of aguidewire having a torque-transmitting tube, although functioning toprovide increased torque transmission, work against and limit theshapeability of the guidewire tip.

BRIEF SUMMARY

The present disclosure relates to guidewire devices having shapeabletips and effective torquability. In one embodiment, a guidewire deviceincludes a core having a proximal section and a tapered distal section.A tube structure is coupled to the core such that the tapered distalsection extends into the tube structure. The tube structure includes aplurality of bypass cuts formed tangentially within the tube structureto increase the flexibility of the tube structure and to reduce thetendency of resilient forces from the tube structure to disrupt a shapeddistal tip of the guidewire device. The bypass cuts are part of a cutpattern which forms a plurality of axially extending beams coupling aplurality of circumferentially and transversely extending rings. Thebypass cuts form a one-beam cut pattern which forms a single beambetween each adjacent ring within the one-beam cut pattern.

Some embodiments further include a coil disposed within the tubestructure so as to be positioned between an outer surface of the distalsection of the core and an inner surface of the tube structure. The coilmay be formed from a radiopaque material, such as platinum. In someembodiments, the core is formed from stainless steel, and the tubestructure is formed from a superelastic material such as nitinol.

In some embodiments, at least a portion of the cut pattern includes asingle-sided one-beam cut pattern wherein a plurality of successivebeams are disposed on a single side of the tube structure with respectto a longitudinal axis of the guidewire device. In some embodiments, thecut pattern includes a two-beam cut pattern disposed proximal of theone-beam cut pattern. The two-beam cut pattern may include adepth-symmetric two-beam cut pattern and a depth-offset two-beam cutpattern, with the depth-symmetric two-beam cut pattern disposed proximalof the depth-offset two-beam cut pattern such that the depth-offsettwo-beam cut pattern functions as a transition between the one-beam cutpattern and the depth-symmetric two-beam cut pattern.

In some embodiments, the one-beam cut pattern is arranged with cuts ofincreasing depth toward a distal end of the tube structure and/or isarranged such that spacing between successive cuts decreases toward adistal end of the tube structure.

In some embodiments, the distal section of the core is formed from ashapeable material and is configured to have a stiffness such that whenthe distal tip is bent into a shaped configuration, the distal sectionof the core is able to withstand deformation caused by an elasticrecovery force of the tube structure

Additional features and advantages will be set forth in part in thedescription that follows, and in part will be obvious from thedescription, or may be learned by practice of the embodiments disclosedherein. The objects and advantages of the embodiments disclosed hereinwill be realized and attained by means of the elements and combinationsparticularly pointed out in the appended claims. It is to be understoodthat both the foregoing brief summary and the following detaileddescription are exemplary and explanatory only and are not restrictiveof the embodiments disclosed herein or as claimed.

BRIEF DESCRIPTION OF THE DRAWINGS

In order to describe the manner in which the above-recited and otheradvantages and features of the invention can be obtained, a moreparticular description of the invention briefly described above will berendered by reference to specific embodiments thereof which areillustrated in the appended drawings. Understanding that these drawingsdepict only typical embodiments of the invention and are not thereforeto be considered to be limiting of its scope, the invention will bedescribed and explained with additional specificity and detail throughthe use of the accompanying drawings in which:

FIG. 1 illustrates an exemplary embodiment of a guidewire deviceproviding effective torquability and having a shapeable tip;

FIG. 2 is a cross-sectional view of the guidewire device of FIG. 1;

FIG. 3 illustrates an exemplary embodiment of a tube structure which maybe utilized with the guidewire device of FIGS. 1 and 2, the tube havinga bypass cut pattern configured to provide effective torquability andeffective shapeability of the distal tip;

FIG. 4 illustrates an alternative embodiment of a tube structureincluding a section having a depth-offset two-beam cut pattern;

FIG. 5 illustrates an embodiment of a tube structure including atwo-beam cut pattern with symmetrically spaced opposing beams;

FIG. 6 illustrates an embodiment of a tube structure including a sectionhaving a single-sided one-beam cut pattern; and

FIG. 7 illustrates an embodiment of a tube structure including a bypasscut pattern with an exemplary angular offset providing a helical patternof resulting beams.

DETAILED DESCRIPTION

The present disclosure relates to guidewire devices providing effectiveanatomical navigation capabilities. The ability to steer and direct aguidewire to a targeted anatomical location depends on balancing andoptimizing tradeoffs between torquability and the ability to maintain ashaped tip. A guidewire device may include a shapeable tip to allow anoperator to point the tip in a desired direction within the vasculatureby rotating the distal tip. However, if the torquability of such aguidewire device is insufficient, the operator will be unable totransmit torsional forces all the way to the shaped distal tip tocontrol the orientation of the shaped distal tip. This hindrance willbecome increasingly problematic as the guidewire device is advancedfarther into the vasculature and experiences increasing frictionalresistance. In addition, if a guidewire device is unable to properlyform and maintain a shaped tip, it will have limited ability to adjusttip orientation, making intravascular navigation more difficult.

Embodiments described herein provide one or more features that balanceand/or optimize the relationship between guidewire torquability and theability to form and maintain a shaped tip. Such guidewires areresponsive to operator manipulation during guidewire deployment, andprovide effective navigation capabilities by enabling a shaped distaltip to receive transmitted torsional forces.

In some embodiments, the shapeable tip allows an operator to customshape the tip, such as by manually shaping the tip just prior todeploying the guidewire device within the patient's vasculature. Theoperator is thus enabled to customize the shaping of the distal tipaccording to preferences and/or conditions particular to a givenapplication. The guidewire device is also configured to effectivelytransmit torque while maintaining the shaped tip. At least someembodiments described herein include tips that are able to maintain abent or curved shape throughout a procedure, or throughout multipleprocedures, or even indefinitely until subjected to a counteractingreshaping force.

FIG. 1 illustrates an exemplary guidewire device 100 having a core 102.A tube 104 is coupled to the core 102 and extends distally from a pointof attachment to the core 102. As shown, a distal section of the core102 extends into the tube 104 and is surrounded by the tube 104. In someembodiments, the core 102 includes one or more tapering sections so thatthe core 102 is able to fit within and extend into the tube 104. Forexample, the distal section of the core 102 may be ground so as toprogressively taper to a smaller diameter at the distal end. In thisexample, the core 102 and the tube 104 have substantially similar outerdiameters at the attachment point 103 where they adjoin and attach toone another.

The tube 104 is coupled to the core 102 (e.g., using adhesive,soldering, and/or welding) in a manner that allows torsional forces tobe transmitted from the core 102 to the tube 104 and thereby to befurther transmitted distally by the tube 104. A medical grade adhesive120 may be used to couple the tube 104 to the core wire 102 at thedistal end of the device and to form an atraumatic covering. Asexplained in more detail below, the tube 104 is micro-fabricated toinclude a plurality of cuts. The cuts are arranged to form a cut patternwhich beneficially provides for effective shapeability near the distaltip of the guidewire device 100 while also maintaining goodtorquability. For clarity, the cut pattern is not shown in FIGS. 1 and2. Examples of cut patterns which may be utilized in the tube 104 areshown in FIGS. 3 through 5.

The proximal section 110 of the guidewire device 100 extends proximallyto a length necessary to provide sufficient guidewire length fordelivery to a targeted anatomical area. The proximal section 110typically has a length ranging from about 50 to 300 cm. The proximalsection 110 may have a diameter of about 0.014 inches, or a diameterwithin a range of about 0.008 to 0.125 inches. The distal section 112 ofthe core 102 may taper to a diameter of about 0.002 inches, or adiameter within a range of about 0.001 to 0.050 inches. In someembodiments, the tube 104 has a length within a range of about 3 to 100cm.

In some embodiments, the distal section 112 of the core 102 tapers to around cross-section. In other embodiments, the distal section 112 of thecore 102 has a flat or rectangular cross-section. The distal section 112may also have another cross-sectional shape, such as another polygonshape, an ovoid shape, an erratic shape, or combination of differentcross-sectional shapes at different areas along its length.

Typically, a user will shape the distal end of the guidewire device 100by manually bending, twisting, or otherwise manipulating the distal 1 cmto 3 cm (approximately) of the guidewire device 100 to a desired shape.This length is shown schematically as the distal “tip” 106 in FIG. 1. Insome embodiments, the tip 106 includes one or more shapeable components(within the tube 104) formed from stainless steel, platinum, and/orother shapeable materials. In preferred embodiments, the tip 106includes one or more components formed from a material that exhibitswork hardening properties, such that the tip, when shaped (i.e.,plastically deformed), provides a higher elastic modulus at the shapedsections than prior to being shaped.

FIG. 2 illustrates a cross-sectional view of the guidewire device 100 ofFIG. 1. As shown, the core 102 includes a proximal section 110 and adistal section 112, with the distal section having a smaller diameterthan the proximal section 110. A coil 114 is positioned upon at least aportion of the distal section 112 of the core 102. The coil 114 ispreferably formed from one or more radiopaque materials, such asplatinum group, gold, silver, palladium, iridium, osmium, tantalum,tungsten, bismuth, dysprosium, gadolinium, and the like. Additionally,or alternatively, the coil 114 may be at least partially formed from astainless steel or other material capable of effectively holding shapedafter being bent or otherwise manipulated by a user. In the illustratedembodiment, the coil 114 is disposed at or near the distal end of thedevice and extends a distance proximally toward the attachment point103. In some embodiments, the coil 114 has a length that substantiallycoincides with the length of the tube 104. In other embodiments, thecoil 114 is shorter. For example, the coil 114 may extend from thedistal end by 1, 2, 4, 6, 8, 10, 12, 15, 20, 25, 30, or 35 cm, or mayextend from the proximal end a distance within a range defined by anytwo of the foregoing values.

In some embodiments, the coil 114 is formed as one integral piece. Inother embodiments, the coil 114 includes a plurality of separatesections positioned adjacent to one another and/or interlocked throughintertwining coils. Such separate segments may additionally oralternatively be soldered, adhered, or otherwise fastened to one anotherto form the complete coil 114.

Although the illustrated embodiment shows a space between the coil 114and the tube 104, it will be understood that this is done schematicallyfor ease of visualization. In some embodiments, the coil 114 is sized tofill and pack a greater proportion of the space between the distalsection 112 and the tube 104. For example, the coil 114 may be sized soas to abut both the distal section 112 of the core 102 and the innersurface of the tube 104. Other embodiments include a space between thecore 102 and the tube 104 for at least a portion of the section of theguidewire device 100 where the tube 104 and the core 102 areco-extensive.

The coil 114 may beneficially function to pack the space between thecore 102 and the tube 104 so as to align the curvature of the distalsection 112 of the core 102 with the curvature of the tube 104. Forexample, when a curvature is formed in the tube 104, the closely packedsegments of the coil 114 functions as a packing between the tube 104 andthe distal section 112 to impart the same curvature to the distalsection 112. In contrast, a guidewire device omitting a coil, whencurved at the tube, would not follow the same curve as the tube butwould extend until abutting against the inner surface of the tube beforebeing forced to curve.

Embodiments described herein beneficially allow the distal tip 106 to beshaped to a desired position and to remain in the shaped position for asufficiently extended period of time. In contrast to a conventionalguidewire device, the illustrated embodiments are able to form andmaintain a shaped configuration. With conventional guidewire devices,problems related to shapeability often occur as a result of a mismatchin properties between the tube structure and the internal components(the core and coil). Tube structures are typically formed from nitinolor other superelastic materials. Such tubes will be, upon being bent orshaped, biased toward their original (straight) position, and willthereby impart recovery forces against any shapeable internalcomponents, resulting in deformation and a loss of the customized shapeof the tip.

Often, for example, a conventional guidewire will have a shaped tipprior to deployment, but the shaped tip will be lost or degraded duringuse of the guidewire as the superelastic tube flexes toward its originalshape in opposition to the desired tip shape. The recovery forcesimparted by the tube thus act against the internal components to reduceor degrade the desired shape set by the user. In contrast, theembodiments described herein includes features that enable the tip 106to be shaped without being subjected to overriding recovery forces fromthe tube. As described below, the tube 104 may include a cut patternwhich maintains effective torquability while also providing sufficientflexibility at the distal tip 106 so as to avoid disrupting the customshape of the tip 106.

FIGS. 3 through 7 illustrate exemplary embodiments of tube cut patternsthat may be utilized in one or more of the guidewire device embodimentsdescribed herein. For example, the tube 104 of the embodiment shown inFIGS. 1 and 2 may be cut according to one or more of the configurationsshown in FIGS. 3 through 7.

FIG. 3 illustrates a tube 504 having a series of cuts 508 which formbeams 530 (extending axially) and rings 540 (extending transversely andcircumferentially). In the illustrated embodiments, the cuts 508 arearranged on the tube as a series of “bypass cuts.” As used herein, abypass cut is a cut that does not have an opposing cut directly oppositeof it with respect to the longitudinal axis of the tube, thereby leavinga single beam 530 of longitudinally extending material between rings 540of transversely and circumferentially extending material. A “bypass” cutpattern may also be referred to herein as a “one-beam” cut pattern. Inthe illustrated embodiment, the cuts are arranged as alternating cutsthat are offset by about 180 degrees from one cut to the next along thelength of the tube 504.

Tubes formed using one or more sections of bypass (i.e., one-beam) cutsas shown can provide a number of benefits, particularly with respect toan associated shapeable tip of a guidewire device. For example, theflexibility of a tube having bypass cuts is relatively greater than theflexibility of a tube having no cuts or having cuts which leave multiplebeams between successive rings (e.g., assuming beam width, ring size,and cut spacing is otherwise equal). Beneficially, the increasedflexibility provided by the bypass cut arrangement minimizes or preventsthe tube from deforming the shape of the internal structures of theguidewire. For example, a core (e.g. stainless steel) disposed within atube may be bent or curved (i.e., plastically deformed) so as to providethe tip of the guidewire with a desired shape.

As explained above, in many instances, forces associated with elasticrecovery of the tube will be imparted against the shaped core and willtend to straighten out the shaped core, at least with respect to theportions of the shaped core that are disposed within the tube.Appropriately tuning the flexibility of the tube therefore reduces therecovery force imparted against the shaped core and allows the shapedcore to better maintain its shape.

In some embodiments, the depth of successive bypass cuts or sets ofbypass cuts is progressively increased for each successive cut or setsof cuts moving toward the distal end. A cut depth profile can thereforebe utilized to configure a tube with the desired flexibility andtorquability characteristics for a given application. For example, onetube configuration can include a proximal section with relatively lowerflexibility and relatively higher torquability that rapidly progressesto a distal section with relatively higher flexibility and relativelylower torquability as bypass cuts rapidly get progressively deepertoward the distal end. In some embodiments, the section havingrelatively deeper cuts is formed only at the distal-most section of thetube where shapeability is expected or desired (e.g., the distal 1 to 3cm of the tube), so as to preserve higher torquability for the remainderof the tube.

Bypass cuts 508 may be varied according to depth, width, and/or spacing.For example, cuts 508 may get progressively deeper and/or more closelyspaced the closer they get to the distal tip of the device. Cuts thatare deeper and/or more closely spaced provide relatively greaterflexibility. Thus, a gradient may be formed which provides forincreasing guidewire flexibility at progressively more distal regions ofthe guidewire. As described in more detail below, bypass cuts 508 mayalso be arranged with alternating angular positions according to anangular offset applied at each adjacent cut or applied at adjacent setsof cuts. The illustrated embodiment shows an angular offset of 180degrees from one cut to the next. Some embodiments may include anangular offset of about 5, 15, 30, 45, 60, 75, 80, or 85 degrees fromone cut to the next or from one set of cuts to the next set of cuts.

FIG. 4 illustrates another embodiment of a tube 604 having bypass cutsand a set of opposing, depth-offset two-beam cuts disposed proximal tothe bypass cuts. In the illustrated embodiment, a set of bypass cutsresults in the beams 630. Proximal to the beams 630 is a set of cutsarranged as opposing cuts which result in beams 634. Although notvisible in this view, an additional beam is formed opposite each beam634 (hidden behind beams 634 in this view). Each ring 640 within thedepth-offset two-beam cut pattern therefore has a set of two beamsconnecting it to its proximally adjacent ring, and a set of two beamsconnecting it to its distally adjacent ring.

As shown, the opposing two-beam cuts are offset in depth so that, foreach opposing cut pair (one cut on each side of the tube axis), one ofthe cuts has a depth that is greater than the opposite cut. Suchdepth-offset two-beam cuts may be advantageously used to transition froma length of bypass cuts (such as shown in FIG. 3) to a length ofnon-offset opposing two-beam cuts (such as shown in FIG. 5).

FIG. 5 illustrates a section of tube 204 having a two-beam cut pattern,with each cut of each opposing cut pair having approximately the samecut depth so that the resulting beams are substantially equallycircumferentially spaced. As shown, the cuts result in a pair of beams234 formed between each of the rings 240. The cuts are shown here asbeing angularly offset by about 90 degrees from one pair of opposingcuts to the next, though other angular offsets may be utilized.

A section of tube having a two-beam cut pattern with substantiallycircumferentially equally spaced beams will typically have relativelyhigher ability to transmit torque and relatively lower flexibility,while a section of tube having bypass cuts will typically haverelatively lower ability to transmit torque and relatively higherflexibility. A section of tube having a depth-offset two-beam cutconfiguration will typically have a torque transmissibility andflexibility between that of a section of depth-symmetric opposingtwo-beam cuts and a section of bypass cuts. The greater the differencebetween the depths of opposing cuts, the closer togethercircumferentially the resulting beams will be, and therefore the moresimilar the offset two-beam cut will be to a one-beam/bypass cut.Likewise, the more similar the depths of the opposing cuts are, the moresimilar the offset two-beam cut will be to a symmetric two-beam cut.

Embodiments of tubes including an offset two-beam section advantageouslyprovide a transition zone that may be positioned and configured toprovide desired transition properties between a distal bypass cut zoneand a proximal symmetric two-beam section. For example, the transitionzone may be relatively gradual or abrupt, depending on the length of thetransition zone and/or depending on the rapidity of change to the offsetin successive cuts. Tubes may therefore be configured to provide aproximal section with greater torquability and less flexibility, whichtransition to a more flexible distal section with greater flexibility tobetter maintain a bent shape when shaped by an operator. The positionsand configurations of the proximal section, transition section, anddistal section are tunable to optimize the benefits of effectivetorquability and shapeable tip performance.

FIG. 6 illustrates another embodiment of a tube 704 having one-beam cutsforming a plurality of beams 730 and rings 740. As shown, the cuts arearranged so that the beams 730 are aligned along one side of the tube704, rather than being alternatingly positioned by 180 degrees or someother angular amount. Such an embodiment can beneficially providepreferential bending in one direction (e.g., toward the aligned beams730) so that the associated recovery force back toward the axis of thetube is further minimized.

FIG. 7 illustrates an embodiment of a tube 304 having a bypass cutpattern and an angular offset between sets of cuts. As shown, theangular offset positions resulting beams 330 in a rotating/helicalcircumferential pattern along the length of the tube section. In someembodiments, a first angular offset is applied from one cut to the nextwithin a set of cuts, and a second angular offset is applied from oneset of cuts to the next set of cuts. For example, as illustrated in FIG.7, each cut 308 in a pair of adjacent cuts may be offset by about 180degrees so as to leave resultant beams 330 on opposite sides of oneanother with respect to the longitudinal axis of the guidewire, whileeach pair is offset from an adjacent pair by some other angular offset(e.g., by about 5 degrees in the illustrated embodiment). In thismanner, the intra-set angular offset can position beams 330 on oppositesides of the guidewire axis, while the inter-set angular offset canadjust the angular position of successive beams enough to minimizepreferred bending directions of the guidewire over a length of severalsets of cuts 308.

Rotational offsets may also be applied to the cut patterns illustratedin FIGS. 3 through 6. In preferred embodiments, each successive cut orsets of cuts (e.g., every second cut, third, fourth, etc.) along thelength of a given section is rotationally offset by about 1, 2, 3, 5, or10 degrees, or is offset by about 1, 2, 3, 5, or 10 degrees off from 90degrees in a two-beam configuration or 1, 2, 3, 5, or 10 degrees offfrom 180 degrees in a one-beam configuration. These rotational offsetvalues have beneficially shown good ability to eliminate flexing bias.

For example, in a two-beam cutting pattern where each pair of beams areequally circumferentially spaced such as shown in FIG. 5, a rotationaloffset that is about 1, 2, 3, 5, or 10 degrees off from 90 degreespositions every other pair of beams along the length of the cut sectionwith a misalignment of a few degrees. For example, a second pair ofbeams may be rotationally offset from a first pair of beams by slightlymore or less than 90 degrees, but a third pair of beams will only berotationally offset from the first pair by a few degrees, and a fourthpair of beams will only be rotationally offset from the second pair by afew degrees. When several successive pairs of beams are arranged thisway along the length of a cut section of the guidewire device, theresulting structure allows the cut pattern to enhance flexibilitywithout introducing or aggravating any directional flexibility bias.

The separate components and features of the tube embodiments shown inFIGS. 3 through 7 may be combined to form different tube configurations.For example, some tubes may be configured so as to have a section ofbypass (one-beam) cuts (as in FIGS. 3, 6, and/or 7) and a section ofsymmetrically spaced two-beam cuts (as in FIG. 5), optionally alsohaving one or more depth-offset two-beam cuts (as in FIG. 4). Forexample, some tube embodiments may include a proximal section having asymmetrically spaced two-beam cut pattern which transitions to a distalsection having a bypass cut arrangement.

The embodiments described herein can beneficially enable more proximalregions of the tube to transmit relatively more torque, while reducingthe torquability of more distal sections of the tube to allow for tipshaping without overly sacrificing torquability. Accordingly, thefeatures of a guidewire device may be tuned to a particular need orapplication to optimize the operational relationship betweentorquability and tip shapeability.

In preferred embodiments, the shapeable distal section of the core has astiffness that is able to withstand an expected bending force from thetube acting upon the distal section of the core after it has beenshaped. In some embodiments, the shapeable distal section of the core isformed from a material or combination of materials providing a modulusof elasticity that is about 1.5 to 4 times greater, or about 2 to 3times greater than the modulus of elasticity of the material(s) used toform the tube.

The terms “approximately,” “about,” and “substantially” as used hereinrepresent an amount or condition close to the stated amount or conditionthat still performs a desired function or achieves a desired result. Forexample, the terms “approximately,” “about,” and “substantially” mayrefer to an amount or condition that deviates by less than 10%, or byless than 5%, or by less than 1%, or by less than 0.1%, or by less than0.01% from a stated amount or condition.

Elements described in relation to any embodiment depicted and/ordescribed herein may be combinable with elements described in relationto any other embodiment depicted and/or described herein. For example,any element described in relation to a tube section of any of FIGS. 3through 7 may be combined and used to form the tube 104 of the guidewiredevice of FIGS. 1 and 2. In addition, embodiments may include a tubehaving a plurality of bypass cuts, depth-offset two-beam cuts, and/ordepth-symmetric two-beam cuts as described herein. In any of theforegoing combinations, the distal tip of the core wire may be rounded,flat, or another shape.

The present invention may be embodied in other forms, without departingfrom its spirit or essential characteristics. The described embodimentsare to be considered in all respects only as illustrative and notrestrictive. The scope of the invention is, therefore, indicated by theappended claims rather than by the foregoing description. All changeswhich come within the meaning and range of equivalency of the claims areto be embraced within their scope.

What is claimed is:
 1. A guidewire device having a shapeable tip, theguidewire device comprising: a core having a proximal section and adistal section, the distal section having a smaller diameter than theproximal section; and a tube structure coupled to the core such that thedistal section of the core passes into the tube structure, wherein thetube structure includes a cut pattern which forms a plurality of axiallyextending beams coupling a plurality of circumferentially extendingrings, wherein at least a portion of the cut pattern includes a one-beamsection having a one-beam cut pattern which forms a single beam betweeneach adjacent ring within the one-beam section, and wherein a distal tipof the guidewire device is configured to be manually shapeable.
 2. Theguidewire device of claim 1, wherein the distal section of the coretapers from the proximal section of the core.
 3. The guidewire device ofclaim 1, further comprising a coil disposed within the tube structure soas to be positioned between an outer surface of the distal section ofthe core and an inner surface of the tube structure.
 4. The guidewiredevice of claim 3, wherein the coil is configured in size and shape topack the space between the outer surface of the distal section of thecore and the inner surface of the tube such that a curvature of the tubestructure is aligned with a curvature of the distal section of the corewhen the tube structure or distal section are curved.
 5. The guidewiredevice of claim 3, wherein the coil is formed at least in part from aradiopaque material.
 6. The guidewire device of claim 1, wherein thecore is formed from stainless steel.
 7. The guidewire device of claim 1,wherein the tube structure is formed from a superelastic material. 8.The guidewire device of claim 7, wherein the tube structure is formedfrom nitinol.
 9. The guidewire device of claim 1, wherein at least aportion of the cut pattern includes a single-sided one-beam cut patternwherein a plurality of successive beams are disposed on a single side ofthe tube structure with respect to a longitudinal axis of the guidewiredevice.
 10. The guidewire device of claim 1, wherein the cut patternincludes a two-beam cut pattern disposed proximal of the one-beam cutpattern.
 11. The guidewire device of claim 10, wherein the two-beam cutpattern includes a depth-symmetric two-beam cut pattern and adepth-offset two-beam cut pattern, wherein the depth-symmetric two-beamcut pattern is disposed proximal of the depth-offset two-beam cutpattern.
 12. The guidewire device of claim 1, wherein the one-beam cutpattern includes a rotational offset such that successive beams or setsof beams along a length of the tube structure are circumferentiallyrotated with respect to a preceding beam or set of beams.
 13. Theguidewire device of claim 12, wherein the rotational offset forms ahelical arrangement of beams along a length of the tube structure. 14.The guidewire device of claim 1, wherein the one-beam cut pattern isarranged with cuts of increasing depth toward a distal end of the tubestructure.
 15. The guidewire device of claim 1, wherein the one-beam cutpattern is arranged such that spacing between successive cuts decreasestoward a distal end of the tube structure.
 16. A guidewire device havinga shapeable tip, the guidewire device comprising: a core having aproximal section and a distal section, the distal section having asmaller diameter than the proximal section; and a tube structure coupledto the core such that the distal section of the core passes into thetube structure, a distal section of the tube structure defining a distaltip of the guidewire device, wherein the tube structure includes aplurality of bypass cuts extending transversely into the tube structure,each bypass cut forming a single beam defined by a remaining section oftube material, wherein the plurality of bypass cuts form rings disposedbetween the bypass cuts and connected by the beams, and wherein thedistal section of the core is formed from a shapeable material and isconfigured to have a stiffness such that when the distal tip is bentinto a shaped configuration, the distal section of the core is able towithstand deformation caused by an elastic recovery force of the tubestructure.
 17. The guidewire device of claim 16, wherein the pluralityof bypass cuts are arranged with cuts of increasing depth toward adistal end of the tube structure.
 18. The guidewire device of claim 17,wherein the plurality of bypass cuts are arranged such that spacingbetween successive cuts decreases toward a distal end of the tubestructure.
 19. The guidewire device of claim 16, further comprising aradiopaque coil disposed within the tube structure so as to bepositioned between an outer surface of the distal section of the coreand an inner surface of the tube structure.
 20. A guidewire devicehaving a shapeable tip, the guidewire device comprising: a core having aproximal section and a distal section, the core tapering from theproximal section to the distal section and the distal section having asmaller diameter than the proximal section; a tube structure coupled tothe core such that the distal section of the core passes into the tubestructure, wherein the tube structure includes a cut pattern which formsa plurality of axially extending beams coupling a plurality ofcircumferentially extending rings, wherein the cut pattern includes adepth-symmetric two-beam section, a depth-offset two-beam section, and aone-beam cut pattern, the depth-symmetric two-beam section beingdisposed proximal of the depth-offset two-beam section, and thedepth-offset tow-beam section being disposed proximal of the one-beamsection, and a coil disposed within the tube structure so as to bepositioned between an outer surface of the distal section of the coreand an inner surface of the tube structure; wherein a distal tip of theguidewire device is configured to be manually shapeable and wherein adistal section of the core coinciding with the distal tip has astiffness such that the distal section of the core is able to withstanddeformation caused by an elastic recovery force of the tube structure.